A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01636492
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: bitopertin Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Single Oral Ascending Dose Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO4917838 in Healthy Male Volunteers.
Study Start Date : November 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Arm Intervention/treatment
Experimental: Bitopertin Drug: bitopertin
Single oral dose
Placebo Comparator: Placebo Drug: placebo
Single oral dose

Primary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: 17 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Area under the concentration-time curve [ Time Frame: Pre-dose and 1, 2, 4, 8, 12, 24, 72, 96, 144, 168 (+/-8), 216 (+/-24), 288 (1/-48) hours post-dose ]
  2. Pharmacokinetics: Urine concentrations drug/metabolites [ Time Frame: Pre-dose and up to 72 hours post-dose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male healthy volunteer, 18 to 60 years of age inclusive
  • Body mass index (BMI) 19-35 kg/m2 inclusive
  • Supine blood pressure within the normal range of the center and heart rate >/= 40 provided QTcB is <450 ms
  • Subjects must agree to use a barrier method of contraception (e.g. condom) for the duration of the study and for 30 days after study completion

Exclusion Criteria:

  • History or evidence of any clinically significant disease or disorder
  • Clinically significant ECG abnormalities
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Previous treatment with iron for iron deficiency anemia
  • Regular smoker (>10 cigarettes, >3 pipefuls or >3 cigars per day)
  • History of alcohol and/or drug abuse or addiction within the last 2 years before study start
  • Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
  • Participation in a clinical study with an investigational drug within the last three months prior to screening
  • Any condition or disease detected during the medical interview/physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigators or their designee

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01636492

New Zealand
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01636492     History of Changes
Other Study ID Numbers: BP19292
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016